At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.

We are looking for a Board-Certified Neurologist Executive Medical Director (EMD) to join our A-team (hybrid*/remote). As an Executive Medical Director at Allucent, you are responsible for advises and assists clients on product development, trial designs, endpoint analyses and the feasibility of conducting Phase I to IV clinical trials in countries proposed by Allucent. Supports Business Development efforts by reviewing the proposal and attending client meetings including Bid Pursuit Meetings and contributes to the identification, development and implementation of the company’s business development strategy.

The Executive Medical Director also oversees the medical and the safety aspects of assigned clinical trials managed by Allucent and provides medical and scientific clinical research expertise into the direction, planning, and interpretation of clinical trials/research and the data collection activities.

In this role you

• Ensure activities meet and integrate with organizational requirements for quality management, health and safety, legal stipulations, environmental policies and general duty of care

• Provide input on, protocol design, strategic clinical recommendations, go/no go decisions, and medical team management of complex trials having multiple medics assigned

• Support Business Development efforts by independently reviewing the proposal, the budget and attending client meetings including Bid Pursuit Meetings

• Advise and assist clients on product development, trial designs, endpoint analyses and the feasibility of conducting Phase I to IV clinical trials in countries proposed by Allucent. Liaise with country managers and department heads at Allucent as needed to meet this task

• Provide therapeutic consultation in support of the scientific, medical, and regulatory operations of the company, including medical assessments on a consultative basis for post marketing activities (e.g., product labelling, health hazard evaluations, etc.)

• Oversee the medical and safety aspects of assigned clinical trials either as the assigned medical monitor or as Therapeutic oversight expert for example answering medical questions from trial team and/or site, assist with protocol interpretation and medical review of generated data including but not limited to clinical laboratory data and case report forms as necessary to ensure adherence to the protocol, consistency and scientific validity of the data. When appropriate, assist the junior medics and Project Managers in discussions with clients on safety issues or concerns that may have arisen.

• Oversee the preparation of the Medical Monitoring and other relevant plans for assigned trials conducted by Allucent prior to the start of the trial

• Oversee the set up and conduct of Data Safety Boards (DSMB, DMB or similar), and Dose escalation meetings (DEC)

• Oversee training of project teams on medical aspects of the trial and therapeutic training as required

• Participate in Investigator meetings, Scientific Advisory Board (SAB) meetings and other meetings where medical expertise is needed

Requirements

• MD Degree

• Board Certified in Neurology

• Minimum 15 years of relevant work experience, including at least 10 years of clinical development experience

• Excellent knowledge of GxP

• Good standing with local, state (in the US), and national licensing and regulatory authorities and certifying bodies

• GDPR/HIPAA, CFR/CTR/CTD and applicable (local) regulatory requirements

• ·Strong written and verbal communication skills including good command of English language

• Effective at problem solving, strategic thinking and conflict resolution

• Strong presentation and networking capabilities

• Excellent organizational, negotiating and financial skills

Benefits

Benefits of working at Allucent include:

• Comprehensive benefits package per location

• Competitive salaries per location

• Departmental Study/Training Budget for furthering professional development

• Flexible Working hours (within reason)

• Opportunity for remote/hybrid* working depending on location

• Leadership and mentoring opportunities

• Participation in our enriching Buddy Program as a new or existing employee

• Internal growth opportunities and career progression

• Financially rewarding internal employee referral program

• Access to online soft-skills and technical training via GoodHabitz and internal platforms

• Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects

• Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees

Disclaimers:

*Our hybrid work policy encourages a dynamic work environment, prescribing 2 days in office per week for employees within reasonable distance from one of our global offices (https://www.allucent.com/careers) .

“The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively “Allucent”). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources.”

#LI-Remote #LI-Hybrid #LI-DH1